title: Phase II trial of biweekly chemotherapy with docetaxel and cisplatin in high-risk patients with unresectable non-small cell lung cancer.
abstract: OBJECTIVE
  We investigated the efficacy and toxicity of a biweekly schedule of docetaxel and cisplatin in high-risk patients with unresectable (stages IIIB-IV) non-small cell lung cancer (NSCLC).
  
  
  METHODS
  In this study, 48 high-risk patients with previously untreated locally advanced or metastatic NSCLC were treated with combination chemotherapy consisting of docetaxel 40 mg/m(2) and cisplatin 40 mg/m(2); both drugs were given biweekly, on days 1 and 15, every 4 weeks in an outpatient setting.
  
  
  RESULTS
  Complete response, partial response, and stable disease were observed in 1 (2.1%), 30 [62.5%, 95% confidence interval (CI) 47.9-77.1], and 4 (8.3%) patients. The median overall survival was 15.1 months (95% CI 11.7-18.5) and the median time to progression was 7.5 months (95% CI 6.4-8.6). The major toxicity was grade 3 anemia in 7 (14.6%) patients. Grade 3/4 neutropenia was observed in 5 (10.4%) patients. Among the nonhematologic toxicities, grade 3 infection and grade 3 diarrhea were observed in 5 (10.4%) and 4 (8.3%) patients, respectively. No treatment-related mortality was found.
  
  
  CONCLUSIONS
  As a front-line chemotherapy for high-risk patients with unresectable NSCLC in an outpatient setting, the biweekly schedule of docetaxel and cisplatin showed feasible efficacy with acceptable hematologic toxicities, comparable to the results of previous studies of triweekly or weekly schedules. Additional large randomized studies are needed to optimize the schedule and dosage of combination therapy with docetaxel and cisplatin in high-risk patients with unresectable NSCLC.
authors.affiliation: Division of Hematology-Oncology, Department of Internal Medicine, Gyeongsang National University School of Medicine, Jinju, Republic of Korea.
authors.forename: Moon Jin
authors.initials: MJ
authors.lastname: Kim
authors.forename: Seok-Hyun
authors.initials: SH
authors.lastname: Kim
authors.forename: Jung Hun
authors.initials: JH
authors.lastname: Kang
authors.forename: Hoon Gu
authors.initials: HG
authors.lastname: Kim
authors.forename: Yu Ji
authors.initials: YJ
authors.lastname: Cho
authors.forename: Yi Yeong
authors.initials: YY
authors.lastname: Jeong
authors.forename: Ho-Cheol
authors.initials: HC
authors.lastname: Kim
authors.forename: Jong Duk
authors.initials: JD
authors.lastname: Lee
authors.forename: Young Sil
authors.initials: YS
authors.lastname: Hwang
authors.forename: Min-Gyo
authors.initials: MG
authors.lastname: Kim
authors.forename: Ja-Yoon
authors.initials: JY
authors.lastname: Choi
authors.forename: Gyeong-Won
authors.initials: GW
authors.lastname: Lee
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use*; D003967:Diarrhea / Q000209:etiology; D000077143:Docetaxel; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000209:etiology; D049268:Positron-Emission Tomography; D043823:Taxoids / Q000009:adverse effects / Q000627:therapeutic use*; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin